[Federal Register Volume 73, Number 46 (Friday, March 7, 2008)]
[Notices]
[Pages 12453-12454]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-4469]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0130]
Determination That RELAFEN (Nabumetone) Tablets and Three Other
Drug Products Were Not Withdrawn From Sale for Reasons of Safety or
Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) has determined that the
four drug products listed in this document were not withdrawn from sale
for reasons of safety or effectiveness. This determination means that
FDA will not begin procedures to withdraw approval of abbreviated new
drug applications (ANDAs) that refer to the drug products, and it will
allow FDA to continue to approve ANDAs that refer to the products as
long as they meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Olivia A. Pritzlaff, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6308, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
sponsors must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. Sponsors of ANDAs do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA). The only clinical
data required in an ANDA are data to show that the drug that is the
subject of the ANDA is bioequivalent to the listed drug.
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(j)(7)),
which requires FDA to publish a list of all approved drugs. FDA
publishes this list as part of the ``Approved Drug Products With
Therapeutic Equivalence Evaluations,'' which is generally known as the
``Orange Book.'' Under FDA regulations, drugs are withdrawn from the
list if the agency withdraws or suspends approval of the drug's NDA or
ANDA for reasons of safety or effectiveness, or if FDA determines that
the listed drug was withdrawn from sale for reasons of safety or
effectiveness (21 CFR 314.162).
Under Sec. 314.161(a) (21 CFR 314.161(a)), the agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved or (2) whenever a listed drug is voluntarily
withdrawn from sale, and ANDAs that refer to the listed drug have been
approved. Section 314.161(d) provides that if FDA determines that a
listed drug was removed from sale for safety or effectiveness reasons,
the agency will initiate proceedings that could result in the
withdrawal of approval of the ANDAs that refer to the listed drug.
FDA has become aware that the drug products listed in the table in
this document are no longer being marketed.
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NDA No. Drug Applicant
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19-583 RELAFEN (nabumetone) GlaxoSmithKline
Tablets, 500 (formerly
milligrams (mg) and SmithKlineBeecham),
750 mg 2301 Renaissance
Blvd., P.O. Box
161540,
King of Prussia, PA
19406-2772
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19-643 MEVACOR (lovastatin) Merck & Co., One Merck
Tablets, 10 mg Dr., P.O. Box 100,
Whitehouse Station,
NJ 08889-0100
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50-416 CORTISPORIN Ophthalmic Monarch
Ointment (bacitracin Pharmaceuticals,
zinc; hydrocortisone; Inc., 501 Fifth
neomycin sulfate; Street,
polymyxin B sulfate) Bristol, TN 37620
400 units/gram (g); 1
percent; equivalent to
3.5 mg base/g; 10,000
units/g
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50-461 ANCEF (cefazolin GlaxoSmithKline
sodium) Injection, 250
mg base/vial, 500 mg
base/vial, 5 g base/
vial
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FDA has reviewed its records and, under Sec. 314.161, has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the agency
[[Page 12454]]
will continue to list the drug products listed in this document in the
``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' identifies, among other items, drug
products that have been discontinued from marketing for reasons other
than safety or effectiveness.
Approved ANDAs that refer to the NDAs listed in this document are
unaffected by the discontinued marketing of the products subject to
those NDAs. Additional ANDAs for the products may also be approved by
the agency if they comply with relevant legal and regulatory
requirements. If FDA determines that labeling for these drug products
should be revised to meet current standards, the agency will advise
ANDA applicants to submit such labeling.
Dated: February 29, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-4469 Filed 3-6-08; 8:45 am]
BILLING CODE 4160-01-S